* M20-404: ABBV-47D11 in Adults Hospitalised with COVID-19
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19
IRAS ID
292363
Contact name
Julie Fox
Contact email
Sponsor organisation
AbbVie UK
Eudract number
2020-005203-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 in participants hospitalised with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.
ABBV-47D11 is an investigational anti-SARS-CoV-2 monoclonal antibody being developed for the treatment of COVID-19. Participants will receive either placebo or ABBV-47D11. There is a 1 in 4 chance that participants will be assigned to placebo.
Around 24 adult participants hospitalised for a diagnosis of COVID-19 will be enrolled in approximately 10 to 30 sites globally.
Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo of Day 1.
There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0183
Date of REC Opinion
19 Feb 2021
REC opinion
Further Information Favourable Opinion